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TerminatedPhase NA

TANTALUS Therapy in Type 2 Diabetic Patients Intolerant or Inadequately Responsive to GLP-1 Receptor Agonist Therapy

Asset

GLP-1 / incretin class catch-all

Listed sites

13

Recruiting sites

Enrollment

20

actual

Study population

Type 2 diabetes

Key I/E criteria

BMI ≤40HbA1c ≤10.5%

Primary endpoint

Decrees in HbA1c of at least 0.5 points (HbA1c, change, Body weight, % change)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01303315
Org study IDMC CPTAN2010-017
Secondary IDPosition IIMetaCure

Timeline

Milestones

Study first posted2011-02-24estimated
Last update posted2016-09-22estimated
Study start2011-01 (month precision)
Primary completion2011-07actual (month precision)
Study completion2011-07actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age21 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Male and female subjects 21 through 70 years of age

2. Type 2 diabetes duration more than 6 months and less than 10 years

3. 7.8% < HbA1c < 10.5% if T2DM duration less than or equal to 5 years

4. 7.8% < HbA1c < 10.0% if T2DM duration more than 5 years

5. BMI < 40 kg/m2

6. Taking at least one oral anti-diabetic medication

7. Patients treated with GLP-1 receptor agonist with at least one oral anti-diabetic medication may be included under the following conditions:

a. The HbA1c, before GLP-1 receptor agonist therapy was administered, was:

i.7.8% < HbA1c < 10.5% if T2DM duration less than 5 years
ii.7.8% < HbA1c < 10.0% if T2DM duration greater than 5 years b. The patient was on GLP-1 receptor agonist therapy for no more than 12 weeks

8. Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods

9. If subject is taking lipid-lowering medication, the treatment must be stable for at least one month prior to enrollment

10. If subject is taking anti-hypertensive medication, the treatment must be stable for at least one month prior to enrollment

11. If subject is taking anti-depressant medication, the treatment must be stable for at least one month prior to enrollment

12. Willingness to refrain from using prescription, over the counter, or herbal weight loss products for the duration of the trial

13. Ability and willingness to perform required study and data collection procedures and adhere to operating requirements of the TANTALUS® System

14. Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial

15. Able to provide voluntary informed consent

Exclusion criteria

1. Insulin therapy within the last 3 months 2. GLP-1 receptor agonist therapy longer than 3 months 3. Diagnosed with renal dysfunction or history of renal dysfunction 4. Taking medications known to affect gastric motility 5. Use of prescription, over the counter or herbal weight loss products or obesity drugs during the past two months 6. Experiencing severe and progressing diabetic complications (7. Prior wound healing problems 8. Diagnosed with past or current psychiatric condition that may impair his or her ability to comply with the study procedures 9. Use of anti-psychotic medications 10. Diagnosed with eating disorder such as bulimia or binge eating 11. Obesity due to an endocrinopathy 12. Hiatal hernia requiring surgical repair or a paraesophageal hernia 13. Pregnant or lactating 14. Diagnosed with impaired liver function 15. Any prior bariatric surgery 16. Any history of pancreatitis 17. Any history of peptic ulcer disease within 5 years of enrollment 18. Diagnosed with Gastroparesis or other GI motility disorder 19. Use of active medical devices (either implantable or external) such as ICD, drug infusion device, or neurostimulator (either implanted or worn). Subjects using an external active device who are able and willing to avoid use of the device during the study may be enrolled.

20. Cardiac history that physician feels should exclude the subject from the study.

21. Use of another investigational device or agent in the 30 days prior to enrollment 22. A history of life-threatening disease within 5 years of enrollment 23. Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing the study

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
1
Other (unclassified)
1

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Decrees in HbA1c of at least 0.5 points and Weight loss of at least 3% of total body weight after 6 month of treatment

Time frame:6 month

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Glycemic and metabolic parameters

Time frame:6 month

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.